Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:17 PM
Ignite Modification Date:
2025-12-24 @ 11:17 PM
NCT ID:
NCT04720456
Eligibility Criteria:
Inclusion Criteria:
* Patients with a diagnosis of chronic liver disease without portal hypertension.
* Patients with a diagnosis of chronic liver disease with portal hypertension.
Exclusion Criteria:
* Subjects who are pregnant.
* Patients with known or suspected hypersensitivity to egg phosphatidyl serine or with a history of anaphylactic allergy to eggs or egg products.
* Subjects with allergy to egg products or other components of the ultrasound contrast agents will be excluded.
* History of allergic reaction to Lumason®, sulfur hexafluoride, sulfur hexafluoride lipid microsphere components, or other ingredients in Lumason (polyethylene glycol, distearoylphosphatidylcholine (DSPC), dipalmitoylphosphatidylglycerol sodium (DPPG-Na), palmitic acid)
* History of allergic reaction to Sonazoid
* Patients with biliary atresia with asplenia or polysplenia.
* Patients with prior liver transplant.
* Patients with cystic fibrosis.
* Patients with chronic lung disease.
* Patients with portal vein thrombosis, cavernous transformation of the portal vein or absent portal vein.
* Adults not competent/impaired.
* Patients with significant heart disease or severe congenital heart disease
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
21 Years
Study:
NCT04720456
Study Brief:
Protocol Section:
NCT04720456